(121 days)
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K/DEN: Not Found
No
The provided text describes a quantitative assay for estradiol using an automated chemiluminescence system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an assay for quantitative determination of estradiol in serum, used to aid in assessing ovarian function and monitoring follicular development. It is a diagnostic tool, not a device that directly treats or provides therapy.
Yes
The intended use explicitly states, "The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradial in serum and to aid in assessing ovarian function and in the monitoring of follicular development," which describes a diagnostic purpose—to aid in assessing a biological function.
No
The summary describes an assay (a chemical test) and an automated chemiluminescence system, which are hardware components used for laboratory analysis. It does not describe a software-only device.
Yes, based on the provided information, the Chiron Diagnostics ACS:180 Estradiol-6 II Assay is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of estradial in serum." This involves testing a biological sample (serum) outside of the body (in vitro) to obtain diagnostic information.
- Purpose: The purpose is to "aid in assessing ovarian function and in the monitoring of follicular development." This is a diagnostic purpose related to a patient's health.
- System: It uses an "automated chemiluminescence system," which is a common type of laboratory instrument used for in vitro diagnostic testing.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This assay fits that description.
N/A
Intended Use / Indications for Use
The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradial in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.
Product codes
CHP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an emblem that appears to be an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 4 1997
Thomas F. Flynn Manager, Regulatory Affairs & Compliance Chiron Diagnostics Corporation 63 North Street Medfield, Massachusetts 02052-1688
K970386 Re: ACS Estradiol-6 II Immunoassay Requlatory Class: I Product Code: CHP Dated: January 31, 1997 Received: February 3, 1997
Dear Mr. Flynn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 320) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Company Confidential
Page
510(k) Number (if known):
Device Name: Chiron Diagnostics ACS:180 Estradiol-6 II Assay
Indications for Use:
The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradial in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K970586
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use لل (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
ACS:180 Estradiol-6 II 510(k)
June 2, 1997